BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 6097332 · Received November 11, 2016

    Report

    Report Number
    2032227-2016-41474
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    August 1, 2016
    Report Date
    October 20, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.(B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HER BLOOD GLUCOSE HAS BEEN HIGH FOR THE PAST COUPLE OF MONTHS; SHE EXPERIENCES HYPERGLYCEMIA EVERY DAY AND A HALF. THE PATIENT'S BLOOD GLUCOSE HAD BEEN IN THE 400 MG/DL RANGE. THE PATIENT FELT SLEEPING, TIRED, AND LETHARGIC. SHE MENTIONED THAT IT HAD BEEN TEN YEARS AFTER A SPINAL SURGERY. THE PATIENT HAD BEEN TREATING WITH INSULIN PUMP THERAPY. SHE HAD BEEN USING MANUAL INSULIN INJECTIONS WHEN HER BLOOD GLUCOSE GOT VERY HIGH. TROUBLESHOOTING WAS NOT COMPLETED. THE RESERVOIR WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748604 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other